Gastroesophageal RefluxPhase 4NCT00299845
Randomized Trial for Pharmacogenomics-based Proton Pump Inhibitor Therapy in Children
A Phase 4 study testing Lansoprazole in people with Gastroesophageal Reflux, run by Osaka University at 1 site in Japan.
Trial summary
Proton pump inhibitors are administered to children as off-label use in Japan. The purpose of this study is to evaluate the effects of CYP2C19 genotypes on pharmacokinetic /pharmacodynamic profiles of PPI in children. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Lansoprazole
- How many people
- 0 participants
- Where
- 1 siteJapan
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with gastroesophageal reflux
- The patient's parent or guardian gives written informed consent including pharmacogenomic analysis
- The patient is willing and able to give assent to participate.
Who cannot join
- Serious hepatic disease, pulmonary disease, renal disease and blood disorder
- Inadequate clinical conditions
Trial locations and contacts
1 site in 1 country.
About this study
Proton pump inhibitors are administered to children as off-label use in Japan. The purpose of this study is to evaluate the effects of CYP2C19 genotypes on pharmacokinetic /pharmacodynamic profiles of PPI in children. The results will provide the beneficial information for the individualized medicine of PPI in children.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Lansoprazole
- Keywords
- gastroesophageal reflux, children, lansoprazole, cytochrome P450 2C19 (CYP2C19), pharmacogenomics, genetic polymorphisms, individualized medicine, pharmacokinetics/dynamics
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LansoprazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Investigators
- Junichi Azuma, MD, Study chair, Graduate School of Pharmaceutical Sciences, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299845
- Sponsor's protocol ID
- PG-ped-LPZ-01
- Status last verified
- Sep 2006
- First submitted
- 6 Mar 2006
- Last updated
- 11 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial for Pharmacogenomics-based Proton Pump Inhibitor Therapy in Children
- ClinicalTrials.gov ID
- NCT00299845
- Acronym / sponsor ID
- PG-ped-LPZ-01
- Conditions
- Gastroesophageal Reflux
- Keywords
- gastroesophageal reflux, children, lansoprazole, cytochrome P450 2C19 (CYP2C19), pharmacogenomics, genetic polymorphisms, individualized medicine, pharmacokinetics/dynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- First posted
- 7 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Proton pump inhibitors are administered to children as off-label use in Japan. The purpose of this study is to evaluate the effects of CYP2C19 genotypes on pharmacokinetic /pharmacodynamic profiles of PPI in children. The results will provide the beneficial information for the individualized medicine of PPI in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients with gastroesophageal reflux
- The patient's parent or guardian gives written informed consent including pharmacogenomic analysis
- The patient is willing and able to give assent to participate.
Key exclusion criteria (2 listed)
- Serious hepatic disease, pulmonary disease, renal disease and blood disorder
- Inadequate clinical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lansoprazole | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junichi Azuma, MD study chair
Graduate School of Pharmaceutical Sciences, Osaka University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lansoprazole in people with Gastroesophageal Reflux, run by Osaka University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2012.